Generic Levofloxacin 500mg Scored Tablets
Scored generic tablets of 500mg levofloxacin, bisectable for dose adjustment in renal impairment. Under HTS 3004.90.92.12 for other anti-infectives containing levofloxacin salts, put up in measured retail doses excluding Chapter exclusions.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If mixed with other antibacterials
Combinations of antibacterials classify separately from single-agent.
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Import Tips & Compliance
• Prove bioequivalence to innovator via FDA abbreviated NDA pathway
• Scored tablets need dissolution profile matching reference
• Generic labeling must avoid trademarked names like Levaquin
Related Products under HTS 3004.90.92.12
Levofloxacin 500mg Tablets
Oral tablets containing 500mg of levofloxacin, a fluoroquinolone antibiotic used to treat bacterial infections such as pneumonia and urinary tract infections. These are unmixed products put up in measured doses for retail sale, specifically classified under HTS 3004.90.92.12 due to the presence of levofloxacin as the active ingredient. They fall in Chapter 30 as medicaments for therapeutic use, excluding goods of headings 3002, 3005, or 3006.
Levofloxacin 750mg Film-Coated Tablets
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Levaquin 750mg Tablets (Branded)
Branded Levaquin tablets with 750mg levofloxacin for community-acquired pneumonia treatment. Falls under HTS 3004.90.92.12 as retail-packed anti-infective medicaments containing levofloxacin salts in measured doses, distinct from immunological products or waste pharma.
Levofloxacin Hemihydrate 250mg Capsules
Capsules containing levofloxacin hemihydrate equivalent to 250mg base, for oral therapy of acute bacterial rhinosinusitis. HTS 3004.90.92.12 covers these as products with levofloxacin salts in retail measured doses for prophylactic/therapeutic use.
Levofloxacin Oral Suspension 25mg/5mL Bottles
Reconstitutable oral suspension bottles with levofloxacin 25mg per 5mL for pediatric use. HTS 3004.90.92.12 includes these liquid medicaments containing levofloxacin in measured doses for retail sale as anti-infectives.
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